Method of treatment for psilocybin or psilocin infusion

Abstract

Methods for treatment for patients suffering from disease or condition are contemplated as including an administration of an intravenous infusion of a pharmaceutically effective amount of psilocybin or psilocin. The intravenous infusion of psilocybin or psilocin may include an additional compound such as a benzodiazepine, preferably lorazepam, administered via a continuous intra-venous infusion. Such methods may be seen to better alleviate the symptoms of psychological conditions, neurological injuries, pain, or inflammatory condition, and may result in reduced need for other medications.

What is claimed is: 
     
         1 . A method of treating a disease or condition in a subject in need thereof, the method comprising intravenously administering to the subject a free base equivalent of from 1 mg to 15 mg of psilocin, or a pharmaceutically acceptable salt thereof, over a period of between 1 minute and 60 minutes. 
     
     
         2 . The method of  claim 1 , wherein a free base equivalent of from 4 mg to 15 mg of psilocin, or a pharmaceutically acceptable salt thereof, is administered to the subject over a period of 20 to 60 minutes. 
     
     
         3 . The method of  claim 2 , wherein a free base equivalent of 5.0±1.0 mg of psilocin, or a pharmaceutically acceptable salt thereof, is administered over a period of 20 to 30 minutes. 
     
     
         4 . The method of  claim 2 , wherein a free base equivalent of 7.5±1.0 mg of psilocin, or a pharmaceutically acceptable salt thereof, is administered over a period of 20 to 45 minutes. 
     
     
         5 . The method of  claim 2 , wherein a free base equivalent of 10.0±2.0 mg of psilocin, or a pharmaceutically acceptable salt thereof, is administered over a period of 30 to 60 minutes. 
     
     
         6 . The method of  claim 1 , wherein a free base equivalent of from 1 mg to 5 mg of psilocin, or a pharmaceutically acceptable salt thereof, is administered to the subject over a period of 2 to 20 minutes. 
     
     
         7 . The method of  claim 6 , wherein a free base equivalent of 4.0±1.0 mg of psilocin, or a pharmaceutically acceptable salt thereof, is administered over a period of 5 to 20 minutes. 
     
     
         8 . The method of  claim 6 , wherein a free base equivalent of 3.0±1.0 mg of psilocin, or a pharmaceutically acceptable salt thereof, is administered over a period of 5 to 15 minutes. 
     
     
         9 . The method of  claim 6 , wherein a free base equivalent of 2.0±1.0 mg of psilocin, or a pharmaceutically acceptable salt thereof, is administered over a period of 2 to 10 minutes. 
     
     
         10 . A method of treating a disease or condition in a subject in need thereof, the method comprising intravenously administering to the subject a pharmacologically effective amount of (i) psilocybin or psilocin, or a pharmaceutically acceptable salt thereof, and (ii) a benzodiazepine, each in an amount that together is effective for the treatment of the disease or condition. 
     
     
         11 . A method of treating a disease or condition in a subject in need thereof, the method comprising administering to the subject a timed intravenous infusion of psilocybin or psilocin, or a pharmaceutically acceptable salt thereof, wherein (i) the timed intravenous infusion is administered at a free base equivalent rate of between 1 mg/hr and 15 mg/hr of psilocin or an equimolar equivalent of psilocybin for a period of time between 10 minutes and 60 minutes; or (ii) the timed intravenous infusion is administered at a free base equivalent rate of between 15 mg/hr and 60 mg/hr of psilocin or an equimolar equivalent of psilocybin for a period of time between 2 minutes and 10 minutes. 
     
     
         12 . The method of  claim 11 , wherein the pharmacologically effective amount of psilocybin or psilocin is administered as a saline solution. 
     
     
         13 . The method of any one of  claims 1 - 12 , wherein the method comprises further administering to the patient a pharmacologically effective amount of an antiemetic agent. 
     
     
         14 . The method of  claim 13 , wherein the antiemetic agent comprises a non-selective 5-HT antagonist, 5-HT3 receptor antagonist, 5-HT4 receptor agonist, CB1 agonist, D2 receptor antagonist, D3 receptor antagonist, GABA receptor agonist, H1 receptor antagonist, muscarinic acetylcholine receptor antagonist, NK1 receptor antagonist, or a combination thereof. 
     
     
         15 . The method of  claim 14 , wherein the anti-emetic ondansetron is intravenously infused. 
     
     
         16 . The method of any one of  claims 1 - 15 , wherein the intravenous infusion comprises a pharmacologically effective amount of a benzodiazepine. 
     
     
         17 . The method of  claim 6 , wherein the benzodiazepine is a 1,4-benzodiazepine, 1,5-benzodiazepine, 2,3-benzodiazepine, triazolobenzodiazepine, imidazobenzodiazepine, oxazolobenzodiazepine, thienodiazepine, thienotriazolodiazepine, thienobenzodiazepine, pyridodiazepine, pyridotriazolodiazepine, pyrralodiazepine, tetrahydroisoquinobenzodiazepine, a benzodiazepine prodrug, or a combination thereof. 
     
     
         18 . The method of  claim 17 , wherein the benzodiazepine is lorazepam or diazepam. 
     
     
         19 . The method of any one of  claims 16 - 18 , wherein the benzodiazepine is administered in a dosage between 2 mg and 10 mg. 
     
     
         20 . The method of any one of  claims 1 - 19 , wherein the intravenous infusion comprises a pharmacologically effective amount of an anesthetic, a sedative, an antiemetic, an anticonvulsant, an antidepressant, an antimigraine, an antipsychotic, an anxiolytic, and/or an antiparkinson agent. 
     
     
         21 . The method of any one of  claims 1 - 20 , wherein the intravenous infusion comprises ondansetron or a pharmaceutically acceptable salt thereof. 
     
     
         22 . The method of any one of  claims 1 - 21 , further comprising administering to the patient a preparation comprising a pharmacologically effective amount of an anti-inflammatory agent. 
     
     
         23 . The method of  claim 22 , wherein the administration of the preparation is an intravenous infusion of ketorolac or pharmaceutically acceptable salt thereof. 
     
     
         24 . The method of  claim 22 , wherein the administration of the preparation is an intramuscular infusion of a pharmacologically effective amount of a triptan or a pharmaceutically acceptable salt thereof. 
     
     
         25 . The method of  claim 24 , wherein the preparation comprises sumatriptan or a pharmaceutically acceptable salt thereof. 
     
     
         26 . The method of any one of  claims 1 - 25 , wherein the rate of administration of the intravenous infusion comprising a pharmacologically effective amount of psilocybin or psilocin is configured to vary during the period of administration. 
     
     
         27 . The method of any one of  claims 1 - 26 , wherein the subject's intensity of experience is monitored. 
     
     
         28 . The method of  claim 27 , wherein the rate of administration of the intravenous infusion comprising a pharmacologically effective amount of psilocybin or psilocin is adjusted in response to the subject's intensity of experience. 
     
     
         29 . The method of any one of  claims 1 - 28 , wherein the patient's plasma concentration of psilocin is monitored. 
     
     
         30 . The method of any one of  claims 1 - 29 , wherein the intravenous infusion comprising a pharmacologically effective amount of psilocybin or psilocin is administered at least twice over the course of a month. 
     
     
         31 . The method of  claim 30 , wherein the intravenous infusion comprising a pharmacologically effective amount of psilocybin or psilocin is administered between 2 and 10 times over the course of a year. 
     
     
         32 . The method of any one of  claims 11 - 31 , wherein the timed intravenous infusion of the pharmacologically effective amount of psilocybin or psilocin is administered at a free base equivalent rate of between 4 mg/hr and 15 mg/hr of psilocin or an equimolar equivalent of psilocybin over a period of time of between 10 minutes and 60 minutes. 
     
     
         33 . The method of  claim 32 , wherein a free base equivalent of 4.0±0.5 mg or 5.0±0.5 mg of psilocin or an equimolar equivalent of psilocybin is administered over a period of 20 to 60 minutes. 
     
     
         34 . The method of  claim 32 , wherein a free base equivalent of 10.0±1.0 mg of psilocin or an equimolar equivalent of psilocybin is administered over a period of 45 to 60 minutes. 
     
     
         35 . The method of any one of  claims 11 - 31 , wherein the timed intravenous infusion of the pharmacologically effective amount of psilocybin or psilocin is administered at a free base equivalent rate of between 15 mg/hr and 30 mg/hr of psilocin or an equimolar equivalent of psilocybin over a period of time of between 2 minutes and 10 minutes. 
     
     
         36 . The method of  claim 35 , wherein a free base equivalent of 1.0±0.5 mg or 2.0±0.5 mg of psilocin or an equimolar equivalent of psilocybin is administered over a period of 2 to 10 minutes. 
     
     
         37 . The method of  claim 35 , wherein a free base equivalent of 4.0±0.5 mg of psilocin or an equimolar equivalent of psilocybin is administered over a period of 5 to 10 minutes. 
     
     
         38 . The method of  claim 35 , wherein a free base equivalent of 5.0±0.5 mg of psilocin or an equimolar equivalent of psilocybin is administered over a period of 10 to 15 minutes. 
     
     
         39 . The method of any one of  claims 1 - 38 , wherein the condition is a psychological condition. 
     
     
         40 . The method of  claim 39 , wherein the psychological condition is evaluated 1-8 weeks after treatment. 
     
     
         41 . The method of  claim 40 , wherein the psychological condition is evaluated 1 week after treatment. 
     
     
         42 . The method of any one of  claims 39 - 41 , wherein the psychological condition is depression, anxiety, addiction, post-traumatic stress disorder, an eating disorder, or compulsive behavior. 
     
     
         43 . The method of  claim 42 , wherein the psychological condition is depression. 
     
     
         44 . The method of  claim 42 , wherein the psychological condition is anxiety. 
     
     
         45 . The method of  claim 44 , wherein the anxiety is of a subject receiving palliative care. 
     
     
         46 . The method of any one of  claims 1 - 38 , wherein the disease or condition is a neurological injury, an inflammatory condition, or pain. 
     
     
         47 . The method of  claim 46 , wherein the disease or condition is an inflammatory condition. 
     
     
         48 . The method of  claim 47 , wherein the inflammatory condition is lung inflammation, neuroinflammation, rheumatoid arthritis, atherosclerosis, psoriasis, type II diabetes, inflammatory bowel disease, Crohn's disease, multiple sclerosis, and/or septicemia. 
     
     
         49 . The method of  claim 48 , wherein the inflammatory condition is chronic obstructive pulmonary disease (COPD), or Alzheimer's disease. 
     
     
         50 . The method of  claim 46 , wherein the disease or condition is a neurological injury. 
     
     
         51 . The method of  claim 50 , wherein the neurological injury is a stroke, a traumatic brain injury, or a spinal cord injury. 
     
     
         52 . The method of  claim 46 , wherein the disease or condition is chronic pain. 
     
     
         53 . The method of  claim 52 , wherein the chronic pain results from post-operative pain, tension headaches, chronic lower back pain, fibromyalgia, nephropathy, multiple sclerosis, shingles, complex regional pain syndrome, cephalic pain, or sciatica. 
     
     
         54 . The method of  claim 53 , wherein the chronic pain condition results from trigeminal autonomic cephalalgia. 
     
     
         55 . The method of  claim 54 , wherein the trigeminal autonomic cephalalgia is selected from the group consisting of episodic and chronic cluster headache (CH), episodic and chronic paroxysmal hemicrania (PH), and short-lasting unilateral neuralgiform headache attacks with conjunctival injection and tearing (SUNCT). 
     
     
         56 . The method of  claim 55 , wherein the trigeminal autonomic cephalalgia is episodic or chronic CH. 
     
     
         57 . The method of any one of  claims 52 - 56 , further comprising administering to the patient one or more medications for pain relief, comprising morphine, hydromorphone, hydrocodone, meperidine, and fentanyl. 
     
     
         58 . The method of any one of  claims 46 - 57 , comprising a timed intravenous infusion of the pharmacologically effective amount of psilocybin or psilocin that is administered at a free base equivalent rate of between 1 mg/hr and 15 mg/hr of psilocin or an equimolar equivalent of psilocybin over a period of time of between 10 minutes and 60 minutes.